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Biosimilar Litigation: Battles Continue Over Launch Notification, Access To FDA Info

 
• By Brenda Sandburg

A look at the status of suits involving Remicade, Neulasta, Epogen and Enbrel proposed biosimilars; Humira patents are being challenged in inter partes review proceedings rather than district court.

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Past performance does not predict future returns in the stock market – or in biosimilar litigation. Pfizer Inc. agreed to Janssen Biotech Inc.'s demand that it not launch Inflectra, a biosimilar to Remicade (infliximab), before Oct. 3. It did so immediately after the U.S. Court of Appeals for the Federal Circuit ruled that 180-day notice of commercial marketing is required after licensure whether or not a biosimilar sponsor has engaged in the patent information exchange process laid out in the biosimilar statute.

But Pfizer is not taking such a conciliatory position in litigation over its biosimilar to Amgen Inc.'s Epogen (epoietin alfa). In that case, Pfizer argues that the Federal Circuit's...

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